There is an ever-increasing demand for more minimally invasive surgical techniques. The lower morbidity seen in endoscopic and arthroscopic surgery makes them very appealing to both patients and physicians. These technologically-advanced procedures include many forms of soft tissue to soft tissue repairs and soft tissue to bone repair. Examples of these procedures in orthopedic surgery include rotator cuff repair, labral repair, biceps tenodesis, and anterior cruciate ligament reconstruction. Other examples in other surgical subspecialties include, but are not limited to, hernia repair, hysterectomies, and laparoscopic gastric bypass.
Many orthopedic surgery procedures involve the use of anchoring devices that attach soft tissue to bone. Most of these procedures and techniques rely on the use of polymers, metal, or biodegradable compounds. The use of these materials often requires relatively large holes placed in bone. If these devices ever loosen, one is faced with the issue of having a potentially hard device in a joint, which can cause degradation of the joint and/or place the patient at risk for developing arthritis. Certain polymeric devices, such as those made with polylactic acid (PLA), can weaken bone, predisposing the patient to fracture. Finally, metal devices can cause scatter on MRI, making follow-up images inaccurate.
In addition, two major challenges facing all surgeons and endoscopic surgeons in particular, are knot tying and suture management. Use of multiple sutures may lengthen procedure time, producing higher risk to the patient and lower repair predictability. Endoscopic knot tying is also very challenging. For example, arthroscopic soft tissue biceps tenodesis requires multiple passes of suture through the tendon and rotator cuff, followed by retrieval and knot tying which require a great deal of skill.
Solutions have been developed as an alternative to complex suture management, particularly for soft tissue to bone fixation. For example, a device that uses predominantly soft, flexible materials in repairs has a number of key advantages: 1) The use of a less invasive techniques for implantation because the use of a material that is less brittle allows the use of smaller holes in bone; 2) The ease of MRI use in follow-up; 3) No risk of a hard device lodging in a joint or body cavity; 4) Potentially better tissue incorporation; 5) Ultimately stronger bone and lower risk of fracture.
Prior solutions for suture anchors using a flexible or suture material have come under criticism for not being stiff enough in their attachment or secure enough without tying a suture knot to fully secure the soft tissue attachment. For example, U.S. application Ser. No. 13/677,112, US publication No. 2013/0123810, the complete disclosure of which is hereby incorporated by reference in its entirety for all purposes and is commonly assigned with the current disclosure. A loose or loosening attachment may enable the tissues to move post procedurally and possibly compromising the healing process. Additionally tying a knot to secure the attachment and prevent loosening is cumbersome during endoscopic or arthroscopic procedures.
Therefore additional solutions have been developed for a device that uses only or predominantly soft flexible materials for soft tissue to bone fixation with a number of key advantages: A device that supplies a mechanism that uses primarily soft flexible materials to provide a strong anchor within the bone and does not require the use of a tertiary knot to secure the attachment so as to prevent the device from loosening.